{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,1]],"date-time":"2026-10-01T04:05:38Z","timestamp":1790827538759,"version":"4.1.0"},"reference-count":17,"publisher":"Oxford University Press (OUP)","issue":"3","license":[{"start":{"date-parts":[[2025,3,7]],"date-time":"2025-03-07T00:00:00Z","timestamp":1741305600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/academic.oup.com\/pages\/standard-publication-reuse-rights"}],"funder":[{"name":"SEIMC-Gesida"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2025,10,6]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:sec>\n                  <jats:title>Background<\/jats:title>\n                  <jats:p>We investigated the efficacy of dolutegravir\/lamivudine for maintenance treatment for people with human immunodeficiency virus (HIV, PWH) and previous lamivudine resistance.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods<\/jats:title>\n                  <jats:p>Open-label, single arm, multicentric clinical trial including virologically suppressed PWH with historical lamivudine resistance (confirmed by genotypic testing or suspected based on clinical history), no integrase resistance and CD4+ &amp;gt;200\u2005cells\/mm3 whose antiretroviral therapy (ART) was changed to dolutegravir\/lamivudine if the M184V\/I mutation was not detected in baseline proviral DNA population sequencing. Proviral DNA next-generation sequencing (NGS) was retrospectively performed in baseline samples. Primary endpoint was proportion of participants with huma immunodeficiency virus type 1 (HIV-1) RNA viral load (VL) \u226550\u2005copies\/mL at 48 weeks in the intention-to-treat-exposed (ITT-e) population using the Food and Drug Administration snapshot algorithm.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>In total, 121 participants enrolled, 114 with a prior genotype with M184V\/I, mean virological suppression of 9 years. And 24 (19.8%) had the M184V\/I in baseline proviral DNA NGS (&amp;gt;5% threshold). At 48 weeks, 4 participants had a VL \u226550 copies\/mL (3.3%, 95% confidence interval [CI]: \u00b7.9%\u20138.2%, FDA-Snapshot ITT-e): 1 confirmed virologic withdrawal, 1 precautionary virologic withdrawal, and 2 discontinued from study treatment for other reasons with last VL \u226550 copies\/mL; none had M184V\/I in baseline proviral DNA NGS, and there was no emergent integrase resistance. Also, 90.1% participants (109\/121) had a VL &amp;lt;50 copies\/mL (95% CI: 83.3%\u201394.8%), and there were no data for 6.6% (8\/121 participants) at 48 weeks.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusions<\/jats:title>\n                  <jats:p>After excluding lamivudine mutations in proviral DNA by population sequencing, dolutegravir\/lamivudine effectively maintained virological suppression in PWH with CD4+ &amp;gt;200 cells\/mm3 and history of lamivudine resistance. Notably, no treatment-emergent resistance was observed.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1093\/cid\/ciaf100","type":"journal-article","created":{"date-parts":[[2025,3,7]],"date-time":"2025-03-07T07:00:29Z","timestamp":1741330829000},"page":"491-498","source":"Crossref","is-referenced-by-count":7,"title":["Dolutegravir\/Lamivudine for Maintenance of Virological Suppression in Persons With Historical Suspected or Confirmed Resistance to Lamivudine: Week 48 Results of a Single-Arm, Open-Label, Multicenter, Phase IIa Clinical Trial"],"prefix":"10.1093","volume":"81","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-2749-818X","authenticated-orcid":false,"given":"Rosa","family":"De Miguel","sequence":"first","affiliation":[{"name":"Hospital Universitario La Paz -IdiPAZ, Internal Medicine Department\/Infectious Diseases Unit , Madrid ,","place":["Spain"]},{"name":"CIBER of Infectious Diseases (CIBERINFEC) , Madrid ,","place":["Spain"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7712-6977","authenticated-orcid":false,"given":"Mar\u00eda","family":"de Lagarde Sebastian","sequence":"additional","affiliation":[{"name":"CIBER of Infectious Diseases (CIBERINFEC) , Madrid ,","place":["Spain"]},{"name":"Hospital Universitario 12 de Octubre, imas12 , HIV Unit, Internal Medicine Department, Madrid ,","place":["Spain"]},{"name":"Medicine Department, Universidad Complutense Madrid (UCM), Madrid ,","place":["Spain"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jos\u00e9 Luis","family":"Blanco Ar\u00e9valo","sequence":"additional","affiliation":[{"name":"Infectious Diseases and AIDS Unit, Infectious Diseases Department Hospital Clinic , Barcelona,","place":["Spain"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Adriana","family":"Pinto-Martinez","sequence":"additional","affiliation":[{"name":"CIBER of Infectious Diseases (CIBERINFEC) , Madrid ,","place":["Spain"]},{"name":"Hospital Universitario 12 de Octubre, imas12 , HIV Unit, Internal Medicine Department, Madrid ,","place":["Spain"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Roc\u00edo","family":"Montejano","sequence":"additional","affiliation":[{"name":"Hospital Universitario La Paz -IdiPAZ, Internal Medicine Department\/Infectious Diseases Unit , Madrid ,","place":["Spain"]},{"name":"CIBER of Infectious Diseases (CIBERINFEC) , Madrid ,","place":["Spain"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0217-5122","authenticated-orcid":false,"given":"Angela","family":"Guti\u00e9rrez Liarte","sequence":"additional","affiliation":[{"name":"Hospital Universitario La Princesa , Madrid ,","place":["Spain"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Roser","family":"Navarro-Soler","sequence":"additional","affiliation":[{"name":"CIBER of Infectious Diseases (CIBERINFEC) , Madrid ,","place":["Spain"]},{"name":"Hospital Universitario 12 de Octubre, imas12 , HIV Unit, Internal Medicine Department, Madrid ,","place":["Spain"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4651-7545","authenticated-orcid":false,"given":"Esperanza","family":"Ca\u00f1as-Ruano","sequence":"additional","affiliation":[{"name":"Department of Infectious Diseases, Hospital del Mar , Barcelona ,","place":["Spain"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alexis","family":"Inciarte","sequence":"additional","affiliation":[{"name":"Infectious Diseases Department, Hospital Cl\u00ednic , Barcelona ,","place":["Spain"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8102-4079","authenticated-orcid":false,"given":"Luz","family":"Martin-Carbonero","sequence":"additional","affiliation":[{"name":"Hospital Universitario La Paz -IdiPAZ, Internal Medicine Department\/Infectious Diseases Unit , Madrid ,","place":["Spain"]},{"name":"CIBER of Infectious Diseases (CIBERINFEC) , Madrid ,","place":["Spain"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8411-1952","authenticated-orcid":false,"given":"Arkaitz","family":"Imaz","sequence":"additional","affiliation":[{"name":"Bellvitge University Hospital, HIV and STI Unit, Department of Infectious Diseases, Bellvitge Biomedical Research Institute (IDIBELL), Barcelona ,","place":["Spain"]},{"name":"Medicine Department, University of Barcelona, L\u2019Hospitalet de Llobregat , Barcelona ,","place":["Spain"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Cristina","family":"Hern\u00e1ndez Guti\u00e9rrez","sequence":"additional","affiliation":[{"name":"Internal Medicine Department, Hospital Universitario Pr\u00edncipe de Asturias de Alcal\u00e1 de Henares , Madrid ,","place":["Spain"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Antonio","family":"Ocampo","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine, Hospital Alvaro Cunqueiro, Unidad de enfermedades Infecciosas , Vigo ,","place":["Spain"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Pedro","family":"Gil Divasson","sequence":"additional","affiliation":[{"name":"Fundaci\u00f3n SEIMC-GESIDA , Madrid ,","place":["Spain"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6912-4736","authenticated-orcid":false,"given":"Rafael","family":"Delgado","sequence":"additional","affiliation":[{"name":"CIBER of Infectious Diseases (CIBERINFEC) , Madrid ,","place":["Spain"]},{"name":"Hospital Universitario 12 de Octubre, imas12, Microbiology Department , Madrid ,","place":["Spain"]},{"name":"Medicine Department, Universidad Autonoma de Madrid , Madrid ,","place":["Spain"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Federico","family":"Pulido","sequence":"additional","affiliation":[{"name":"CIBER of Infectious Diseases (CIBERINFEC) , Madrid ,","place":["Spain"]},{"name":"Hospital Universitario 12 de Octubre, imas12 , HIV Unit, Internal Medicine Department, Madrid ,","place":["Spain"]},{"name":"Medicine Department, Universidad Complutense Madrid (UCM), Madrid ,","place":["Spain"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7410-9450","authenticated-orcid":false,"given":"Jose R","family":"Arribas","sequence":"additional","affiliation":[{"name":"Hospital Universitario La Paz -IdiPAZ, Internal Medicine Department\/Infectious Diseases Unit , Madrid ,","place":["Spain"]},{"name":"CIBER of Infectious Diseases (CIBERINFEC) , Madrid ,","place":["Spain"]},{"name":"Medicine Department, Universidad Autonoma de Madrid , Madrid 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initiation of the dual therapy dolutegravir + lamivudine in the maintenance DOLULAM pilot study","volume":"72","author":"Charpentier","year":"2017","journal-title":"J Antimicrob Chemother"},{"key":"2025100602574391200_ciaf100-B7","doi-asserted-by":"crossref","first-page":"1920","DOI":"10.1093\/cid\/ciz1243","article-title":"Efficacy and safety of switching to dolutegravir\/lamivudine fixed-dose 2-drug regimen vs continuing a tenofovir alafenamide\u2013based 3- or 4-drug regimen for maintenance of virologic suppression in adults living with human immunodeficiency virus type 1: phas","volume":"71","author":"van Wyk","year":"2020","journal-title":"Clin Infect Dis"},{"key":"2025100602574391200_ciaf100-B8","doi-asserted-by":"crossref","first-page":"ofac107","DOI":"10.1093\/ofid\/ofac107","article-title":"Dolutegravir monotherapy as maintenance strategy: a meta-analysis of individual participant data from randomized controlled trials","volume":"9","author":"Fournier","year":"2022","journal-title":"Open Forum Infect Dis"},{"key":"2025100602574391200_ciaf100-B9","doi-asserted-by":"crossref","first-page":"253","DOI":"10.1016\/S1473-3099(19)30036-2","article-title":"Dolutegravir versus ritonavir-boosted lopinavir both with dual nucleoside reverse transcriptase inhibitor therapy in adults with HIV-1 infection in whom first-line therapy has failed (DAWNING): an open-label, non-inferiority, phase 3b trial","volume":"19","author":"Aboud","year":"2019","journal-title":"Lancet Infect Dis"},{"key":"2025100602574391200_ciaf100-B10","doi-asserted-by":"crossref","first-page":"e381","DOI":"10.1016\/S2352-3018(22)00092-3","article-title":"Efficacy and safety of dolutegravir or darunavir in combination with lamivudine plus either zidovudine or tenofovir for second-line treatment of HIV infection (NADIA): week 96 results from a prospective, multicentre, open-label, factorial, randomised, non-","volume":"9","author":"Paton","year":"2022","journal-title":"Lancet HIV"},{"key":"2025100602574391200_ciaf100-B11","article-title":"Dolutegravir with Recycled NRTIs is Noninferior to PI-Based ART: VISEND Trial. #135, Oral 12","author":"Mulenga"},{"key":"2025100602574391200_ciaf100-B12","doi-asserted-by":"crossref","first-page":"e384","DOI":"10.1016\/S2352-3018(17)30069-3","article-title":"Boosted protease inhibitor monotherapy versus boosted protease inhibitor plus lamivudine dual therapy as second-line maintenance treatment for HIV-1-infected patients in sub-Saharan Africa (ANRS12 286\/MOBIDIP): a multicentre, randomised, parallel, open-la","volume":"4","author":"Ciaffi","year":"2017","journal-title":"Lancet HIV"},{"key":"2025100602574391200_ciaf100-B13","doi-asserted-by":"crossref","first-page":"198","DOI":"10.1093\/cid\/ciae006","article-title":"Two cases of viral re-suppression after M184V + R263K selection on DTG\/3TC without treatment 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different genotyping techniques (GEN-PRO study)","volume":"76","author":"Montejano","year":"2021","journal-title":"J Antimicrob Chemother"},{"key":"2025100602574391200_ciaf100-B17","doi-asserted-by":"crossref","first-page":"1","DOI":"10.1093\/ofid\/ofad526","article-title":"Virologic response to dolutegravir plus lamivudine in people with suppressed human immunodeficiency virus type 1 and historical M184V\/I: a systematic literature review and meta-analysis","volume":"10","author":"Kabra","year":"2023","journal-title":"Open Forum Infect Dis"}],"container-title":["Clinical Infectious 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